Liang Fan, Leland Hyuma, Jedrzejewski Breanna, Auslander Allyn, Maniskas Seija, Swanson Jordan, Urata Mark, Hammoudeh Jeffrey, Magee William
Keck School of Medicine of USC, Los Angeles, CA.
University of Maryland, Baltimore, MD.
J Craniofac Surg. 2018 May;29(3):584-593. doi: 10.1097/SCS.0000000000004300.
Alveolar cleft reconstruction has historically relied on autologous iliac crest bone grafting (ICBG), but donor site morbidity, pain, and prolonged hospitalization have prompted the search for bone graft substitutes. The authors evaluated bone graft substitutes with the highest levels of evidence, and highlight the products that show promise in alveolar cleft repair and in maxillary augmentation. This comprehensive review guides the craniofacial surgeon toward safe and informed utilization of biomaterials in the alveolar cleft.A literature search was performed to identify in vitro human studies that fulfilled the following criteria: Level I or Level II of evidence, ≥30 subjects, and a direct comparison between a autologous bone graft and a bone graft substitute. A second literature search was performed that captured all studies, regardless of level of evidence, which evaluated bone graft substitutes for alveolar cleft repair or alveolar augmentation for dental implants. Adverse events for each of these products were tabulated as well.Sixteen studies featuring 6 bone graft substitutes: hydroxyapatite, demineralized bone matrix (DBM), β-tricalcium phosphate (TCP), calcium phosphate, recombinant human bone morphogenic protein-2 (rhBMP-2), and rhBMP7 fit the inclusion criteria for the first search. Through our second search, the authors found that DBM, TCP, rhBMP-2, and rhBMP7 have been studied most extensively in the alveolar cleft literature, though frequently in studies using less rigorous methodology (Level III evidence or below). rhBMP-2 was the best studied and showed comparable efficacy to ICBG in terms of volume of bone regeneration, bone density, and capacity to accommodate tooth eruption within the graft site. Pricing for products ranged from $290 to $3110 per 5 mL.The balance between innovation and safety is a complex process requiring constant vigilance and evaluation. Here, the authors profile several bone graft substitutes that demonstrate the most promise in alveolar cleft reconstruction.
从历史上看，牙槽嵴裂修复一直依赖于自体髂嵴骨移植（ICBG），但供区并发症、疼痛和住院时间延长促使人们寻找骨移植替代物。作者评估了证据级别最高的骨移植替代物，并重点介绍了在牙槽嵴裂修复和上颌骨增量手术中显示出前景的产品。这篇综述指导颅面外科医生在牙槽嵴裂修复中安全、明智地使用生物材料。
进行了文献检索，以确定符合以下标准的体外人体研究：证据级别为I级或II级，受试者≥30名，以及自体骨移植与骨移植替代物之间的直接比较。进行了第二次文献检索，涵盖了所有评估用于牙槽嵴裂修复或牙种植体牙槽骨增量的骨移植替代物的研究，无论其证据级别如何。还列出了每种产品的不良事件。
16项研究涉及6种骨移植替代物：羟基磷灰石、脱矿骨基质（DBM）、β-磷酸三钙（TCP）、磷酸钙、重组人骨形态发生蛋白-2（rhBMP-2）和rhBMP7，符合首次检索的纳入标准。通过第二次检索，作者发现DBM、TCP、rhBMP-2和rhBMP7在牙槽嵴裂文献中研究最为广泛，不过这些研究的方法学往往不够严谨（证据级别为III级或更低）。rhBMP-2研究得最为充分，在骨再生量、骨密度以及移植部位容纳牙齿萌出的能力方面，其疗效与ICBG相当。产品价格从每5毫升290美元到3110美元不等。
创新与安全之间的平衡是一个复杂的过程，需要持续的警惕和评估。在此，作者介绍了几种在牙槽嵴裂重建中最具前景的骨移植替代物。
